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Exploring the Effects of Exercise Combined With BFRT on Healthy and Patients With CKD

ConditionChronic Kidney Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-85
SponsorNational Cheng Kung University

About this trial

Investigate the effects of exercise training on the cardiopulmonary function and exercise capacity in healthy and CKD patients

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Severe uncontrolled metabolic diseases (e.g., hyperthyroidism, diabetes, hypertension, hyperlipidemia, etc.)

Severe pulmonary or cardiovascular diseases (e.g., pulmonary hypertension, chronic obstructive pulmonary disease (COPD), heart failure, cardiac arrhythmia)

Presence of a cardiac pacemaker or a history of myocardial infarction within the past six months

Severe musculoskeletal or neuromuscular disorders (e.g., advanced arthritis, limb amputation, post-polio syndrome, Parkinson's disease)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Aerobic exercise

    Behavioral

    The aerobic exercise intervention will utilize stationary bike. The program will be conducted 2 times per week over a 12 weeks

  • Blood flow restriction

    Behavioral

    Blood flow restriction intervention will combined aerobic exercise and resistance exercise. The program will be conducted 2 times per week over a 12 weeks

  • Resistance exercise

    Behavioral

    The resistance exercise will bilateral leg extension. The program will be conducted 2 times per week over a 12 weeks

  • Disease and exercise suggestion

    Behavioral

    The participants will received self-care technique and home-based exercise approach

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: healthyExperimental treatment 4 interventions
Group B: CKD usual care groupActive comparator 1 intervention
Group C: CKD traditional rehabilitation groupActive comparator 3 interventions
Group D: CKD BFR groupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Diaphragm excursion and thickness

Diaphragm excursion (unit: mm) and thickness (unit: mm) are examined by diaphragmatic ultrasound when a participant performs maximal inspiration and expiration

Time frame
Change from baseline (0 week) to follow up (16 weeks)
2

Exercise capacity

A cardiopulmonary exercise test collects gases (including measures of oxygen consumption in ml/kg/min), which can be used to estimate exercise capacity

Time frame
Change form baseline (0 week) to follow up (16 weeks)

Secondary outcomes

1

Heart rate variability (Standard Deviation of Normal-to-Normal Intervals, SDNN)

Heart rate variability (HRV) is examined to assess the autonomic nervous system. Standard Deviation of Normal-to-Normal Intervals (SDNN, in ms)reflects overall heart rate variability and autonomic function

Time frame
Change form baseline (0 week) to follow up (16 weeks)
2

Heart rate variability (Root Mean Square of Successive Differences, RMSSD)

Root Mean Square of Successive Differences (RMSSD in ms) represents short-term HRV and parasympathetic activity

Time frame
Change form baseline (0 week) to follow up (16 weeks)
3

Heart rate variability (Low Frequency power, LF)

Low frequency power (LF, in ms²) reflects both sympathetic and parasympathetic modulation.

Time frame
Change form baseline (0 week) to follow up (16 weeks)
4

Heart rate variability (High Frequency power, HF)

High frequency power (HF in ms²) reflects parasympathetic (vagal) activity.

Time frame
Change from baseline (0 week) to follow-up (16 weeks)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Cheng Kung University

Lead sponsor

Source ClinicalTrials.gov
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